Titanium dioxide free white film coating composition, process for preparing the same, and method of use thereof

Abstract

To provide an effective white and bright titanium dioxide free film coating composition that is suitable for coating solid substrates such as tablets, granules, lozenges, candy, or seeds that carry active ingredients.SOLUTION: A titanium dioxide free white film coating composition comprises: (i) from 20 wt.% to 50 wt.% of hydroxypropyl methyl cellulose (HPMC), a water-soluble cellulose ether; (ii) from 5 wt.% to 15 wt.% of carboxy methyl cellulose (CMC), a water-soluble anionic cellulose ether; (iii) from 10 wt.% to 60 wt.% of calcium carbonate (CaCO3); and (iv) from 5 wt.% to 25 wt.% of a plasticizer.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] This application relates to coating compositions, and more particularly to titanium dioxide-free white film coatings. The present invention relates to a film coating composition, a method for preparing the same, and a method for coating a solid substrate. [Background technology]

[0002] Coatings are used in pharmaceutical, veterinary, agricultural, nutritional, automotive, biochemistry, chemistry, computer science, and other fields. in many industries, including petroleum, consumer goods, food, electronics, materials, and healthcare. The existence of coatings across so many application areas is The coatings provide a wide range of functions, such as protection (e.g., water absorption, UV damage), isolation (e.g., chemical incompatibility), changes in the release of the active ingredient (e.g., immediate, extended, delayed, controlled release), and by altering sensory perception (e.g. smoothness / roughness, taste, color).

[0003] Titanium dioxide (TiO2) has become an undesirable colorant worldwide for a number of reasons: New or alternative ingredients and components that can replace the need and uses for titanium dioxide The search for titanium dioxide is becoming important for coatings within many industrial segments. Such new alternative ingredients for tanning are particularly relevant in agricultural, micronutritional, and / or pharmaceutical fields. Tablets, capsules, granules, lozenges, candies or seeds containing an active ingredient such as an active ingredient The objective of the present invention is to improve the visual appeal, whiteness and brightness of such substrates or materials.

[0004] U.S. Patent No. 4,931,286 (assigned to Aqualon Company) is a tablet 0.1 to 5.0% by mass of sodium carboxymethylcellulose and polyethylene glycol A high gloss pharmaceutical tablet having an outer coating of cholesteryl phosphate is disclosed.

[0005] U.S. Patent No. 10,159,650 (Assigned to Sensient Colors LLC) ) is a composite of hydroxypropyl methylcellulose (HPMC), cellulose polymers, and precipitated carbon A film coating composition comprising a calcium carbonate, an opacifying agent, and a fatty acid is disclosed.

[0006] However, the carboxymethyl cellulose carbonate containing coating compositions of the prior art sodium (NaCMC) or precipitated calcium carbonate (CaCO3) provides good opacity This is ineffective in reducing the amount of paint that is applied, resulting in a dull, grayish coloration of the coated product or substrate. It has been observed to exhibit an appearance. Summary of the Invention [Problem to be solved by the invention]

[0007] Thus, active ingredients, including but not limited to agricultural, nutritional, and / or pharmaceutical actives, To a coated solid substrate such as a tablet, granule, lozenge, candy or seed The art is now clear for a suitable, effective, white, bright titanium dioxide-free film coating composition. It is necessary.

[0008] Surprisingly, we have found that (i) the gloss and bright appearance are improved, and (ii) the coated Titanium dioxide-free film coating composition discovered to improve whiteness of coated solid substrates did. [Means for solving the problem]

[0009] (Summary of the Invention) A film coating that imparts better properties to the final or finished product than those of the prior art. These coatings consist of (i) water-soluble cellulose ethers, (ii) water-soluble anionic cellulose ether, (iii) calcium carbonate (CaCO ), and (iv) plasticizers.

[0010] In one embodiment of the present invention, the following is provided: (i) 20% by weight to 50% by weight of hydroxypropyl methyl (ii) 5% to 15% by weight of HPMC, a water-soluble cellulose ether; Carboxymethyl cellulose (CMC), a water-soluble anionic cellulose ether; iii) 10% to 60% by weight of calcium carbonate (CaCO3); and (iv) 0.0 A titanium dioxide-free white film coating composition containing 5% to 5% by weight of a plasticizer is Provided.

[0011] According to another aspect of the present application, the total solids content ranges from about 10% to about 25% by weight of the total composition. A white film coating composition having an amount of

[0012] In another embodiment, the composition comprises 0.001% to 25% by weight of red iron oxide, black iron oxide, or The pigment further includes an optional secondary pigment, including but not limited to combinations thereof. A colorant coating composition is disclosed.

[0013] In yet another aspect, a method for preparing a white film coated substrate comprises the steps of: (a) preparing a coating suspension comprising the white film coating composition described above; (b) applying the coating suspension of step (a) to the surface of a solid substrate to coat it. (c) simultaneously and / or subsequently drying the coating layer to form a dry coating. (d) forming a film-coated film on the surface of the solid substrate; and A method is disclosed that includes obtaining a solid substrate.

[0014] According to another embodiment, a method for producing a coating composition comprising the steps of: (a) preparing a coating composition comprising the above-described white film coating composition; (b) preparing a coating suspension containing the coating suspension of step (a) (c) simultaneously and / or subsequently applying the coating to the surface of the article to form a coating layer; drying the coating layer to form a dry coating on the surface of the solid product; and and (d) producing the desired final film-coated solid product. A solid product coated with a white film is disclosed.

[0015] The objects, features and advantages of the present invention will become apparent from the following description taken in conjunction with the drawings / figures. It will become clear. [Brief explanation of the drawings]

[0016] [Figure 1] Figure 1 shows comparative tablets coated with hydroxypropyl methylcellulose (HPMC) and hydroxypropyl cellulose (HPC) showing poor opacity and dull appearance. [Figure 2] FIG. 2 compares an image of the prior art coating with Applicant's coating, which is whiter and brighter. [Figure 3] FIG. 3 is a front view of the whiteness of the tablet showing an image of the prior art coating (greyish, dull appearance) compared to the applicant's coating (whiter, brighter). [Figure 4] FIG. 4 is a front view of tablet whiteness contrast showing images of applicant's coated tablets versus the control. [Figure 5]FIG. 5 shows the opacity of Applicant's film coatings and standard film coatings. [Figure 6] FIG. 6 is a graphical representation of the gloss and surface roughness parameters of Applicant's film coating and the standard film coating. [Figure 7] FIG. 7 is a scanning electron microscope image showing the effect of calcium carbonate particle size on coating opacity. [Figure 8] FIG. 8 is a photograph of coated tablets showing the effect of calcium carbonate particle size on coating brightness. DETAILED DESCRIPTION OF THE INVENTION

[0017] The specification concludes with claims particularly pointing out and distinctly claiming what is regarded as the invention. However, by reading the following detailed description of the invention and examining the included examples, It is expected that the invention will be easier to understand.

[0018] When used in accordance with this disclosure, unless otherwise indicated, the following terms have the following meanings: It is understood that

[0019] Unless otherwise defined herein, in connection with the inventive concepts disclosed and / or claimed Technical terms used shall have the meanings commonly understood by those skilled in the art. In addition, unless otherwise required by context, singular terms shall include pluralities and plural uses shall not be construed as limiting the scope of the invention. Words are intended to include the singular.

[0020] The singular forms "a," "an," and "the" are used unless the context clearly indicates otherwise. or includes the plural unless the contrary is clearly indicated by the context in which reference is made. As used in the specification, "comprising" (and "comp Any of the words "comprising" such as "comprises" and "comprises" Form), "having" (and "have" and "ha any form of having, such as "having" (including "including"), "including" such as "includes" and "include" any form) or "containing" (and "contains " and any form of containing, such as "contain" The terms may be inclusive or open-ended and may not exclude additional, unrecited elements or method steps. stomach.

[0021] For purposes of the following detailed description, other than in any operational example or unless otherwise indicated, For example, numbers representing the amounts of ingredients used in the specification and claims should be understood in all instances to be modified by the term "about." The numerical parameters set forth in this specification and appended claims are intended to define the present invention. These are approximations that may vary depending on the desired properties to be obtained in a given implementation.

[0022] All percentages, parts, proportions and ratios used herein are indicative of amounts unless otherwise specified. All such weights relating to listed ingredients are by weight of the active ingredient. The solvents are based on the level and therefore may be present in commercially available materials unless otherwise stated. Or does not contain by-products.

[0023] All publications, articles, papers, patents, patent publications, and other references cited herein To the extent consistent with the disclosure herein, the same is hereby incorporated in its entirety for all purposes. Be absorbed.

[0024] As used herein, the terms "applicant's coating," "sample," and "inventive coating" refer to "coating" is interchangeable and refers to the coating composition of the present claim. The terms "solid substrate" and "solid material" are interchangeable in the current application.

[0025] As used herein, the term "HPC" refers to hydroxypropyl cellulose.

[0026] As used herein, the term "HPMC" refers to hydroxypropyl methylcellulose. say.

[0027] As used herein, the term "MCT" refers to medium chain triglycerides.

[0028] As used herein, the term "PEG" refers to polyethylene glycol.

[0029] As used herein, the term "NaCMC" refers to sodium carboxymethyl cellulose. This refers to the word ``mu.''

[0030] As used herein, the term "solid substrate" or "solid material" or "solid product" refers to a tablet. This refers to, but is not limited to, powders, granules, lozenges, candies, seeds, etc.

[0031] This application is particularly directed to a white film cover that provides unique advantages or properties not found in the prior art. The coating is a water-soluble cellulosic coating. cellulose polymer, water-soluble anionic cellulose polymer, calcium carbonate, plasticizer and others These coatings are based on a combination of optional ingredients. Compared to existing coatings, Provides improved film coating that is whiter, brighter and glossier in appearance .

[0032] In one embodiment, the present application provides a method for producing a hydroxypropyl cellulose film comprising: (i) 20% to 50% by weight of hydroxypropyl cellulose; (ii) 5% by weight to 15% by weight of hydroxymethylcellulose (HPMC), a water-soluble cellulose ether; % by weight of carboxymethyl cellulose (CMC), a water-soluble anionic cellulose ether (iii) 10% to 60% by weight of calcium carbonate; and (iv) 5% to 25% by weight of calcium carbonate. % of a plasticizer.

[0033] Additionally, the white film coating composition may contain 0.0 wt % to 5 wt % medium chain triglycerides. cerides (MCT), and 0.0% to 2% by weight of citric acid monohydrate.

[0034] In another embodiment of the present application, the white film coating composition comprises about 10 parts by weight of the total composition. In a non-limiting embodiment of the present application, the solids content ranges from about 25% to about 25% by weight. Other possible ranges of content include about 10% to about 15% by weight of the total composition; about 15% to about 20% by weight; or about 20% to about 25% by weight of the total composition These may include, but are not limited to:

[0035] In another embodiment, the water-soluble cellulose ether has the general structure represented below: [ka] wherein each R1, R2, R3, R4, R5, and R6 is independently substituted to form a suitable functional group. They form cellulose ether derivatives with a carbon atom. CMC, hydroxyethyl cellulose (HEC), hydroxy Propyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC) and These cellulose esters include, but are not limited to, methyl cellulose (MC). The ethers are available in terms of various R functional groups, degree of hydroxyl group substitution, and their molecular weight ranges. The difference is in the range.

[0036] Hydroxypropyl methylcellulose, also known by its acronym HPMC, is a pharmaceutical The high-quality grade is also known by the common chemical name hypromellose. HPMC is partially O- Methylated and O-(2-hydroxypropylated) cellulose, wherein R1 , R2, R4, and R5 are OH, OCH3, and / or O[CH3CH(OH)CH2] y; and R3 and R6 are CH2OH, CH2OCH3 and / or CH2O[CH3 CH(OH)CH2] y where the subscript "y" is the number of hydroxypropyl monomer units For purposes of the present invention, commercially available HPMC is referred to as Dow Chemical (Met. hocel™ grades E3, E5, E6, E15, E50, E4M, E10M, F 50, K3, K100, K4M, K15M, K100M), Shin-Etsu Che Mical Company (Pharmacoat Grades 603, 606, 615, 904), and Hercules Inc. (Benecel® MP 84 3, 814, and 844). [ka] HPMC is present in an amount of 20-50% by weight based on the total weight of the coating composition, preferably 2 HPMC is present in an amount of 0-45% and more preferably 25-45%. Grades can exist.

[0037] Hydroxypropyl cellulose (HPC) is a partially substituted poly(hydroxypropyl) cellulose. hydroxyethyl ether, wherein R1, R2, R4 and R5 are OH and / or O [CH2(CH(CH3)O] y H; R3 and R6 are CH2OH or CH2O[C H2CH(CH3)O] y H, where the subscript "y" is hydroxypropyl This represents the number of monomer units. HPC grades manufactured by Ashland LLC and Examples include Klucel (registered trademark) EF, LF, HF, JF, LF, MF, and GF. can be. [ka]

[0038] Sodium carboxymethylcellulose (NaCMC) is a water-soluble anionic cellulose Sodium carboxymethylcellulose is a polycarboxymethylcellulose of cellulose. where R1, R2, R4 and R5 are OH. R3 and R6 are CH2OCH2COONa. Commercially available NaCMC contains these Products include, but are not limited to, Hercules Inc. under the trade names Aqualon® and and Blanose®. The chemical and physical properties of NaCMC are It has found wide application in pharmaceuticals, personal care, etc. Methylcellulose has the following structure: [ka] Carboxymethyl cellulose is used in an amount of 5 to 15 times based on the total weight of the coating composition. % by weight, 5-10% by weight, or 10-15% by weight. There may be present carboxymethylcellulose.

[0039] The calcium carbonate (CaCO3) useful here can be obtained from natural deposits and then , finely ground or obtained by chemical precipitation and drying of the precipitate. It is used as a filler in paintings, rubber, paper, food, medicine, plastics, etc. Um is an opacifying agent that provides excellent brightness and whiteness without the use of compounds containing heavy metals. and / or opacity. The morphology of the carbon dioxide provides increased surface area and disperses more uniformly in aqueous media. The form and particle size of calcium influence the whiteness and opacity of the film coating. Calcium carbonate morphology includes prismatic and scale structures. The particle size of the calcium carbonate used in the coating composition is between 0.5 microns and 20 microns. Therefore, the particle size of calcium carbonate is 0.5 microns to about 5 microns; Can be up to 10 microns; 10 microns to 15 microns; 15 microns to 20 microns More preferably, the present application provides a mean particle size of 1.8 to 2.0 microns and a scalenohedral molar ratio of 1.8 to 2.0 microns. Calcium carbonate having good rheology is used. Calcium carbonate is used in the composition. 60% by mass, preferably 15 to 55% by mass, more preferably 20 to 50% by mass Blends of different particle sizes and morphologies are contemplated.

[0040] The plasticizer is present at about 5% to about 30% by weight to increase plasticity or flowability. Plasticizers, for example, can improve flexibility and stiffness by lowering the glass transition temperature (Tg) of the composition. Improve the plastic properties of the polymer composition by increasing its strength and / or durability. Some plasticizers are subject to direct or indirect human use via several end-user products. Examples of such plasticizers are acetyl tributyl, acetone, citrates selected from tyltriethyl, tributyl and triethyl citrate; poly A glycol selected from ethylene glycol (PEG), propylene glycol, and glycerin. phthalates selected from dibutyl, diethyl and dimethyl phthalates; glycol; stearic acid selected from ceryl monostearate; and triacetin. In one or more embodiments, the coating composition may include PEG 200, PEG 300, PEG400, PEG600, PEG1000, PEG1500, PEG400 0, PEG3350, PEG6000 and PEG8000. In another non-limiting embodiment of the present application, in addition to the plasticizer, a PEG selected from the group Possible ranges of are about 5% by weight to about 10% by weight, about 10% by weight to about 15% by weight , about 15% to about 20% by weight, about 20% to about 25% by weight, or about 15% to about 20% by weight of plasticizer 30% by weight, but is not limited to these.

[0041] In another embodiment, the present application provides a method for producing a glycerol having a chain length of 8 to 12 carbon atoms and a 3 Esters derived from three fatty acids are provided as medium-chain triglycerides (MCTs). The main fatty acid components are caprylic acid, capric acid, and lauric acid. The medium-chain fatty acids may be referred to herein as C8 fatty acids or C8. A medium chain fatty acid having 1,000,000 atoms may be referred to herein as a C10 fatty acid or C10. MCTs are used in a variety of applications, including as a food additive and in the treatment of neurological disorders. The film coating composition typically contains 0.0% to 5% by weight of medium chain triglycerides (M CT).

[0042] In another embodiment, the present application further provides citric acid in either monohydrate or anhydrous form. Citric acid acts as an acidifier, antioxidant, buffer, chelating agent or flavor enhancer. Citric acid monohydrate is widely used in pharmaceutical preparations and foods as a crystalline solid in dry air. The film coating composition of the invention contains 0. Citric acid monohydrate may be included in an amount of from 0.0% to 2.0% by weight.

[0043] Suitable pigments include iron oxides, e.g., FD&C Lake, Carmine Lake, and FD&C Blue. No. 1, FD&C Blue No. 2, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Green No. 3, Red Iron Oxide, Alumina, Talc, Turmeric Oleic Acid , coquina extract, gardenia extract, gardenia yellow, gardenia blue, beet powder, etc. Examples of colorants, dyes and lakes include, but are not limited to: The pigment present in the film coating composition is from 0.001% to 25% by weight, Preferably, it may be 0.01% by weight to 10% by weight, and red iron oxide, black iron oxide or the like may be used. The compound may be selected from the group including, but not limited to, a combination of:

[0044] In another embodiment, the present application provides a method for producing a pulverized ... A coating formulation is provided that is dry blended with foodstuffs. Solid ingredients such as glycerides (G) and medium chain triglycerides (MCT) can be used as plasticizers. do.

[0045] In another embodiment, the present application is directed to a method for preparing a white film coated solid substrate. The present invention provides a method for making the following: (a) a white film composition as described herein; (b) preparing a coating suspension comprising the coating composition of step (a); (c) applying the coating suspension to the surface of the solid substrate to form a coating layer; The coating layer is simultaneously or subsequently dried to form a dry coating on the surface. (d) obtaining a final coated solid product or substrate. Includes.

[0046] In another embodiment, the solid coated substrate of the present application is an agricultural product, a nutritional product, or a pharmaceutical product. It is a product.

[0047] In another embodiment, the present application relates to tablets, mini-tablets, pellets, capsules, granules, lozenges, A pharmaceutical product or substrate coated on an oral solid dosage form selected from multiparticulates, etc., is formulated. to provide.

[0048] In yet another embodiment, the present application provides (a) a white film coating as described herein. (b) preparing a coating suspension comprising the coating composition of step (a); (c) simultaneously and / or (d) applying the suspension to the surface of the solid product to form a coating layer; Or, the coating layer is then dried to form a dry coating on the surface of the solid product. and (d) obtaining the final film-coated solid product. The present invention provides a white film coated solid product produced by a method comprising:

[0049] In another embodiment, the present application relates to a solid product or substrate coated agricultural product, coated White film coated solid products or substrates that are nutritional products or coated pharmaceutical products In a preferred embodiment, the white film-coated pharmaceutical product is a pharmaceutical oral solid dosage form. These formulations include tablets, mini-tablets, pellets, capsules, granules, and Includes, but is not limited to, Zenzi and multiparticulates.

[0050] In another embodiment, the present application provides improved gloss, surface roughness, opacity, color, etc. We provide titanium dioxide-free coating systems, contributing to improved quality and processability. are.

[0051] (glossy) By way of illustration and not limitation, tablet gloss may be measured by a gloss meter / surface analysis system. Measured. Acceptable edges are clearly defined. Unacceptable edges are not defined. Current titanium dioxide-free film coating systems meet the 60 glu standard. The results are shown in Figure 6. Applicant's coating compositions show higher gloss values.

[0052] (surface roughness) For purposes of illustration and not limitation, prior to determining the surface roughness, the roughness image is analyzed and displayed. Corrected for surface curvature, the shape of the feature to be removed should match the general shape of the tablet. The roughness of a sample set is reported as the average roughness value of 16 tablets in the sample. The results are shown in Figure 6 and show that the roughness is approximately 2.5 square microns, while the standard exhibited a roughness value of 3 square microns, which indicates that the surface roughness decreases with the current coating composition. Indicates that.

[0053] (color) Product colors are determined by reflectance measurements for purposes of illustration and not limitation. The color change was analyzed visually and the applicant's film coating was found to be effective at 5% weight gain. Figure 3 shows that the color becomes brighter and whiter. The effect of this process was experimentally demonstrated and the results are shown in Figure 4, where the reflectance value was 1.42. The coefficient of the standard coating is close to that of the applicant's coating, which is 0.63, and the black When applied to colored tablets, Applicant's TF (titanium free) coating provides 5% by weight The color turned white as the temperature increased. The experimental results are shown in Figure 5.

[0054] (Opacity and white coating rate) For purposes of illustration and not limitation, opacity is measured by scanning electron microscopy (SEM). The higher the light reflectance, the more opaque the film and the whiter the coated substrate. The results are shown in Figures 7 and 8.

[0055] In yet another embodiment of the present application, it is a composition comprising cellulose ether, calcium carbonate, a plasticizer The combination of this and other ingredients in this application dramatically increases the surface area available for angular reflection, increasing gloss. Adds high opacity, brightness, whiteness, and reduces surface roughness to the coated substrate or product. It was found that the white film coating reduces the These coating parameters are provided in Table 9. Such film coatings are , especially when compared to other types of coatings in the related art, The brightness and luminosity are known to those skilled in the art. These coatings are more effective than conventional HPC-based coating systems. Further advantages of the coating composition are illustrated in the examples.

[0056] The following examples are intended to illustrate, but by no means limit, the scope of the present invention. It is not intended to limit the scope of the invention. [Example]

[0057] (Example 1: Coating Method-A) Developed a coating formula with a solid concentration range of 10%-15% and contained hydroxypropyl Hydroxymethylcellulose (HPMC), Carboxymethylcellulose (CMC), Citric acid It contained acetic acid monohydrate and polyethylene glycol.

[0058] [Table 1]

[0059] (Example 2: Coating Method-B) A coating method was developed with a solid concentration range of 15%-20% and hydroxypropyl HPMC, carboxymethylcellulose (CMC), citric acid monohydrate It contains three different components: hydrate, medium-chain triglyceride, and polyethylene glycol. was.

[0060] [Table 2]

[0061] (Example 3: Coating Method C) We developed a coating method and used hydroxypropyl methylcellulose (HPMC), Carboxymethylcellulose (CMC), calcium carbonate, citric acid monohydrate, polyethylene It contained two different grades of glycol and medium chain triglycerides.

[0062] [Table 3]

[0063] (Example 4: Coating Method-D) We developed a coating method and used hydroxypropyl methylcellulose (HPMC), Carboxymethylcellulose (CMC), calcium carbonate, citric acid monohydrate, polyethylene It contained ethylene glycol and medium chain triglycerides.

[0064] [Table 4]

[0065] (Example 5: Coating Method-E) We developed a coating method and used hydroxypropyl methylcellulose (HPMC), 2. Composition of carboxymethylcellulose (CMC), calcium carbonate, and polyethylene glycol It contained three different grades.

[0066] [Table 5]

[0067] (Example 6: Coating Method-F) We developed a coating method and used hydroxypropyl methylcellulose (HPMC), Hydroxyethyl cellulose (HEC), carboxymethyl cellulose (CMC), carbonate Contains calcium, citric acid monohydrate, polyethylene glycol and medium chain triglycerides was doing.

[0068] [Table 6]

[0069] (Example 7: Coating Method-G) A coating method was developed with a solid concentration range of 15%-20% and hydroxypropyl HPMC, carboxymethyl cellulose (CMC), calcium carbonate Iron oxide, red iron oxide, black iron oxide, citric acid monohydrate, medium chain triglycerides and polyethylene It contained three different types of glycol.

[0070] [Table 7]

[0071] Example 8: Improving color uniformity Placebo tablets were coated at 25% solids at high speed. Application of the formulated white film coating composition improves color uniformity. As shown in Figures 1 and 2, the tablets that are the subject of the applicant's coating The agent is white and bright.

[0072] Example 9: Comparative Coating Scheme Using Hydroxypropyl Cellulose We developed a coating method and used ingredients such as hydroxypropyl cellulose (HPC) and hydroxypropyl cellulose. HPMC, carboxymethyl cellulose (CMC), charcoal Calcium carbonate, yellow iron oxide, citric acid monohydrate, medium chain triglyceride and polyethylene glycol The HPC coated tablets had poor opacity and edge chipping. The results are shown in Figure 3.

[0073] [Table 8]

[0074] Example 10: Better Opacity & Better Whiteness Coverage The white film made from powdered titanium dioxide is the whitest and most opaque film with high reflectivity. To provide a reflection index, white film paint opacity is typically achieved using titanium dioxide. To achieve the same opacity as titanium dioxide, it is combined with cellulose ethers. The applicant developed a coating formula by changing the particle size of calcium carbonate. The diameters are 0.7 microns, 1.8 microns and 2.0 microns with a scalenhedral structure. The smaller particles give better coverage, but the larger particles This book uses calcium carbonate with an average particle size of 1.8-2.0 microns and a skeletal structure. Applicant's coatings are the most effective when compared to 0.7 micron prismatic calcium carbonate. The final coverage showed better opacity and better coverage. The results are shown in Figures 7 and 8.

[0075] Example 11: Coating Attributes [Table 9]

[0076] The compositions and methods of the disclosed and / or claimed inventive concepts are described in terms of specific embodiments. Although the present invention has been described, it is understood that the scope of the disclosed and / or claimed inventive concept may be different from the concept, spirit, and scope of the disclosed and / or claimed inventive concept. Without departing from the scope of the present invention, the compositions and / or methods described herein and steps It will be apparent to those skilled in the art that variations can be applied in the steps or sequence of steps. All such similar substitutes and modifications apparent to those skilled in the art are intended to be included within the scope of the disclosure and / or patent. are deemed to be within the spirit, scope and concept of the claimed inventive concept.

Claims

1. A titanium dioxide-free white film coating composition comprising: (i) 20% to 50% by weight of hydroxypropyl methylcellulose (HPMC), water Soluble cellulose ethers; (ii) 5% to 15% by weight of carboxymethyl cellulose (CMC), a water-soluble anion carboxylic cellulose ethers; (iii) 10% to 60% by weight of calcium carbonate (CaCO ３ ); and (iv) 5% to 25% by weight of a plasticizer.

2. The composition comprises 0.0% to 5% by weight of medium chain triglycerides (MCTs), and 0.0 10. The white film coating of claim 1, further comprising citric acid monohydrate in an amount of from 10 to 2% by weight. ting composition.

3. 10. The method of claim 1, wherein the composition has a total solids content ranging from about 10% to about 25% by weight.

1. A white film coating composition as described above.

4. 2. The white film of claim 1, wherein the plasticizer is polyethylene glycol (PEG). Film coating compositions.

5. 1. A method for preparing a white film coated substrate, comprising: (a) creating a coating suspension comprising the white film coating composition of claim 1; Step of releasing; (b) applying the coating suspension of step (a) to the surface of a solid substrate to form a coating layer; forming a (c) simultaneously and / or subsequently drying the coating layer to solidify the dry coating; forming a substrate on a surface thereof; and (d) Obtaining the final white film coated solid substrate.

6. 6. The method of claim 5, wherein the solid substrate is an agricultural product, a nutritional product, or a pharmaceutical product.

7. A white film coated solid product made by a process comprising the steps of: (a) creating a coating suspension comprising the white film coating composition of claim 1; Step of releasing; (b) applying the coating suspension of step (a) to the surface of the solid product to form a coating layer; forming a (c) simultaneously and / or subsequently drying the coating layer to solidify the dry coating; forming on the surface of the body product; and (d) Obtaining the final film-coated solid product.

8. The coated product may be a coated agricultural product, a coated nutritional product or a coated 8. The white film-coated solid product of claim 7, which is a pharmaceutical product.

9. 9. The coated pharmaceutical product of claim 8, wherein the coated pharmaceutical product is formulated into a pharmaceutical oral solid dosage form. A solid substrate coated with a white film.

10. The oral solid dosage forms include tablets, capsules, granules, lozenges, candies and seeds.

9. The white film-coated solid substrate of claim 8, wherein the white film is selected from the group consisting of:

Images